Država: Avstralija
Jezik: angleščina
Source: Department of Health (Therapeutic Goods Administration)
ciprofloxacin hydrochloride, Quantity: 294.586 mg (Equivalent: ciprofloxacin, Qty 250 mg)
Strides Pharma Science Pty Ltd
ciprofloxacin hydrochloride
Tablet, film coated
Excipient Ingredients: microcrystalline cellulose; colloidal anhydrous silica; sodium starch glycollate type A; povidone; magnesium stearate; titanium dioxide; hypromellose; macrogol 400
Oral
28, 60, 14
(S4) Prescription Only Medicine
Ciprofloxacin is indicated for the treatment of infections caused by susceptible organisms in the conditions listed below: Urinary tract infections; Gonorrhoeal urethritis and cervicitis; Gastroenteritis; Bronchial Infections; Skin and skin structure infections; Bone and joint infections; Chronic bacterial prostatitis of mild to moderate severity. Inhalational anthrax (post-exposure): To reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. Ciprofloxacin serum concentrations achieved in humans serve as a surrogate endpoint reasonably likely to predict clinical benefit and provide the basis for this indication. Note: Typhoid and Paratyphoid infections and infections due to multi-resistant Staphylococcus aureus are excluded from the above due to insufficient data. Because Gram-positive organisms are generally less sensitive to ciprofloxacin, it may not be the drug of choice in cases with Gram-positive infections, such as pneumonia due to Streptococcus pneumoniae. Chronic bacterial prostatitis should be demonstrated by microbiological evidence localising infection to the prostate. Strains of Neisseria gonorrhoea resistant to ciprofloxacin have been reported in Australia. Appropriate culture and susceptibility tests should be performed before treatment in order to determine organism susceptibility to ciprofloxacin and after treatment as warranted by the clinical condition. Therapy with Ciprofloxacin may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued. Ciprofloxacin is suitable to treat mixed infections caused by susceptible strains of both Gram-negative and Gram-positive aerobic bacteria. If anaerobic organisms are suspected as accompanying aetiologic agents, additional therapy should be considered.
Visual Identification: White to off-white, round, film coated tablets, with a score line on one side & debossed with F & 23 with a score line in between on the other side; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2011-12-16
LOXIP™ 250, 500 & 750 CONSUMER MEDICINE INFORMATION Ciprofloxacin hydrochloride 250 mg, 500 mg and 1000 mg film-coated tablets WHAT IS IN THIS LEAFLET The leaflet answers some common questions about LOXIP tablets. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking LOXIP tablets against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT LOXIP IS USED FOR LOXIP tablets are used for the treatment of infections of the lungs, skin, bones, joints, kidneys, bladder, prostate and bowel. LOXIP is also used to treat inhalation anthrax (an infection caused by breathing in the spores of bacteria). LOXIP tablets contain the active ingredient, CIPROFLOXACIN, which is an antibiotic belonging to a group of medicines called quinolones (pronounced kwin-o-lones). These antibiotics work by killing the bacteria that are causing your infection. LOXIP will not work against infections caused by viruses such as colds or the flu. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. BEFORE YOU TAKE IT _ _ _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE LOXIP IF YOU HAVE AN ALLERGY TO: ciprofloxacin, the active ingredient in LOXIP; any of the ingredients listed at the end of this leaflet; or other medicines belonging to the quinolone chemical family (e.g. moxifloxacin, norfloxacin, nalidixic acid). Some of the symptoms of an allergic reaction may include: shortness of breath; wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; or rash, itching or hives on the skin. DO NOT TAKE LOXIP IS YOU ARE ALSO TAKING A MEDICINE CALLED TIZANIDINE, A MUSCLE RELAXANT USED TO TREAT SPASTICITY Preberite celoten dokument
Page 1 of 18 PRODUCT INFORMATION LOXIP™ 250, 500 & 750 FILM-COATED TABLETS NAME OF THE MEDICINE Active ingredient: Ciprofloxacin hydrochloride Chemical name: 1-Cyclopropyl-6-fluoro-4-oxo-7-(piperazin-1-yl)-1,4- dihydroquinoline-3- carboxylic acid hydrochloride CAS number: 86393-32-0 Molecular weight: 367.8 Molecular formula: C 17 H 19 ClFN 3 O 3, _x_H 2 O Chemical structure: DESCRIPTION Ciprofloxacin hydrochloride is a pale yellow crystalline powder, slightly hygroscopic. It is soluble in water, slightly soluble in methanol, very slightly soluble in anhydrous ethanol, practically insoluble in acetone, in ethyl acetate and in methylene chloride. LOXIP is available as tablets containing 250 mg, 500 mg & 750 mg ciprofloxacin (as hydrochloride). LOXIP tablets contain the following inactive ingredients: Microcrystalline cellulose, sodium starch glycollate type A, povidone, colloidal anhydrous silica, magnesium stearate, hypromellose, macrogol 400 & titanium dioxide. PHARMACOLOGY PHARMACOLOGICAL ACTIONS (MICROBIOLOGY) Ciprofloxacin has_ in vitro_ activity against a wide range of Gram-negative and Gram- positive organisms. The bactericidal action of ciprofloxacin appears to result from interference with the enzyme, DNA gyrase. Ciprofloxacin is usually active against the following organisms_ in vitro_. Page 2 of 18 Gram-Negative: _Escherichia coli; Klebsiella _species (including _Klebsiella pneumoniae _and_ Klebsiella _ _oxytoca); Enterobacter _ species_; Citrobacter _ species_; Salmonella _ species_; Shigella _ species_; _ _Proteus _ _mirabilis; _ _Proteus _ _vulgaris; _ _Providencia _ _stuartii; _ _Providencia _ _rettgeri (formerly Proteus rettgeri); Morganella morganii (formerly Proteus morganii); _ _Serratia_ species_* _ (_including _ _Serratia _ _marcescens), _ _Pseudomonas _ _aeruginosa, _ _Pseudomonas _ _fluorescens, _ _Campylobacter _ species_, _ _Haemophilus _ _influenzae, _ _Moraxella (Branhamella) catarrhalis. _ _ _ Gram-Positive*: _Staphylococcus aureus _ (including methicillin-susceptible and methicillin-r Preberite celoten dokument